MP 153/2026 pre držiteľa rozhodnutia o registrácii lieku k predkladaniu komunikácie týkajúcej sa prerušenia/zrušenia dodávok lieku

Methodological guideline MP 153/2026 establishes a unified procedure for marketing authorization holders of human medicinal products. This procedure concerns the submission of communications regarding the interruption or cancellation of medicine supplies, known as Medicine Shortage Communications (MSC). The main objective is to ensure that marketing authorization holders submit these notifications for approval by the relevant authorities. Once approved, this important information is distributed to healthcare professionals. This ensures that healthcare professionals are timely and uniformly informed about medicine availability. The guideline is crucial for managing situations where there is a risk of medicine shortages in the market. It helps maintain smooth and standardized communication between pharmaceutical companies and the healthcare sector. Its purpose is to streamline the process of notifying about medicine supply disruptions.